Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID04799912

Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)

Led by University Hospital, Bordeaux · Updated on 2025-02-11

4200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether elective labor induction at 39 weeks of gestation can reduce the rate of cesarean delivery in low-risk first-time pregnant women. This trial aims to confirm findings from a previous large U.S. study, the ARRIVE trial, in a French setting where cesarean rates and pregnancy characteristics differ. The study addresses concerns about whether routine induction at 39 weeks improves outcomes without increasing risks to mothers or babies. Participants are randomly assigned to one of two groups: elective labor induction between 39 weeks 0 days and 39 weeks 4 days using oxytocin and, if needed, cervical ripening techniques for an unfavorable cervix; or expectant management with standard follow-up until at least 41 weeks, with induction only if medically indicated or at 41 to 42 weeks per guidelines. The trial compares these approaches in terms of cesarean delivery rates and other maternal and neonatal outcomes. During the study, participants will have regular obstetrical care and monitoring according to French guidelines. Researchers will assess the incidence of cesarean sections as the primary outcome, along with various secondary outcomes including operative deliveries, maternal complications, and neonatal health measures. The study will continue until delivery, with follow-up through hospital discharge to evaluate safety and satisfaction. The total participation duration depends on gestational age at enrollment and delivery timing.

CONDITIONS

Brief Title

Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Nulliparous women (no previous pregnancy beyond 20 weeks)
  • Singleton pregnancy (one baby)
  • Gestational age between 37 weeks 0 days and 38 weeks 6 days based on first trimester ultrasound
  • Affiliated with or beneficiary of a health security system
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • First ultrasound after 14 weeks gestation
  • Planned labor induction before 40 weeks 5 days
  • Planned cesarean delivery or contraindication to labor
  • Breech baby presentation
  • Multiple pregnancy
  • Signs of labor (regular contractions with cervical change)
  • Fetal death or major fetal abnormalities
  • Use of heparin or low-molecular weight heparin during pregnancy
  • Placenta previa, accreta, or vasa previa
  • Active vaginal bleeding beyond bloody show
  • Ruptured membranes
  • Cervical cerclage in current pregnancy
  • Known low amniotic fluid levels
  • Fetal growth restriction (estimated weight below 10th percentile)
  • Known HIV positive status
  • Major maternal medical illnesses increasing pregnancy risk
  • Refusal of blood products
  • Contraindication to oxytocin
  • Participation in other interventional labor or delivery studies
  • Planned delivery outside study network sites
  • History of uterine surgery such as myomectomy or metroplasty
  • Under legal protection
  • Poor understanding of French language

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Elective Labor Induction or Expectant Management

Duration - From 39 weeks up to 42 weeks of gestation

Participants will either undergo elective labor induction at 39 weeks of gestation or expectant management with standard follow-up until at least 41 weeks, with induction if medically indicated or at 41 to 42 weeks.

1 to 2 visits depending on labor induction or expectant management

Post-delivery Assessment

Duration - Up to 3 to 5 days after delivery

Participants are assessed for maternal and neonatal outcomes including cesarean rate, complications, and satisfaction during hospital stay following delivery.

Hospital stay for delivery and post-delivery assessments

Trial Site Locations

Total: 1 location

1

CHU de Bordeaux

Bordeaux, France

Actively Recruiting

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Research Team

L

Loic Sentilhes, MD, PhD

H

Hugo Madar, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Study protocol FRENCH-ARRIVE: labor induction in low-risk nulliparous women at 39 weeks of gestation to reduce cesarean births: a randomized trial of induction versus expectant management in France.

Hugo Madar, Jean-Marie Chrétien, Hanane Bouchghoul...

https://pubmed.ncbi.nlm.nih.gov/42098695